Trials最新文献

{"title":"Correction: The UPDATE trial (UVB Phototherapy in Dermatology for Atopic Eczema): study protocol for a randomized controlled trial of narrowband UVB with optimal topical therapy versus optimal topical therapy in patients with atopic eczema.","authors":"Eva Knöps, Phyllis Spuls, Ruben Duijnhoven, Marcel Dijkgraaf, Marit van Barreveld, Bernd Arents, Annefoor van Enst, Floor Garritsen, Maruschka Merkus, Maritza Albertina Middelkamp-Hup, Annelie Musters, Angela Bosma, Ariënna Hyseni, Jitske Dijkstra, Dirk Jan Hijnen, Louise Gerbens","doi":"10.1186/s13063-025-08774-1","DOIUrl":"10.1186/s13063-025-08774-1","url":null,"abstract":"","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"55"},"PeriodicalIF":2.0,"publicationDate":"2025-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11834574/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143441933","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Therapeutic exercises, manual therapy, and health education program for adolescents with temporomandibular disorders: face-to-face and online multimodal rehabilitation protocol for a randomized controlled clinical trial.","authors":"Andreza Garrett, Daniela Aparecida Biasotto Gonzalez, Anelise Sonza","doi":"10.1186/s13063-024-08642-4","DOIUrl":"10.1186/s13063-024-08642-4","url":null,"abstract":"<p><strong>Background: </strong>Multimodal rehabilitation has shown good results in adults with temporomandibular disorder (TMD), but there is still doubt regarding the protocol's ideal format (face-to-face or online), and its effectiveness among adolescents. The purpose of this study is to describe a randomized clinical trial protocol of face-to-face and online multimodal rehabilitation, in adolescents with TMD, and to determine its effects on pain, peripheral oxygenation of the masseter muscle, and mandibular range of motion, kinesiophobia and parafunction.</p><p><strong>Methods: </strong>A randomized, controlled clinical trial, blinded to statistical analyses, will be carried out, involving 26 adolescents, diagnosed with TMD. After randomization, the participants will be allocated into two groups: (1) telerehabilitation and (2) face-to-face treatment groups. Each group will undergo an initial assessment, followed by three treatment sessions, reassessment, and follow-up. Appointments and reassessments will be face-to-face, with instruments validated and adapted for adolescent age groups. The intervention protocol also aims at practicality, ease of execution, and strategies for the patient to easily self-manage and perform independently, adapted for face-to-face or online formats. The Diagnostic Criteria for Temporomandibular Disorders, physical and psychosocial aspects, algometry, near-infrared spectroscopy, and the Tampa scale for kinesiophobia will be used to assess the outcomes.</p><p><strong>Discussion: </strong>It is expected that this study will contribute to online and face-to-face assessments and demonstrate the differences in the practice of rehabilitation of adolescents with TMD. Data will be published after the study is completed, and if the benefits are proven, care modalities may be implemented.</p><p><strong>Trial registration: </strong>REBEC-RBR-5scd5tm, UTN code: U1111-1288-4495 . Registered on 19 May 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"54"},"PeriodicalIF":2.0,"publicationDate":"2025-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11829351/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143425719","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effectiveness of human albumin for clinical outcome in aneurysmal subarachnoid hemorrhages: a protocol for randomized controlled (HASH) trial.","authors":"Arshad Ali, Mohsin Khan, Nissar Shaikh, Amr El Mohamad, Mazyona Al-Maadhadi, Noman Shah, Yousef Al-Najjar, Abdul Salam, Ghaya Al-Rumaihi, Ali Ayyad, Sirajeddin Belkhair, Ghanem Al-Sulaiti","doi":"10.1186/s13063-025-08762-5","DOIUrl":"10.1186/s13063-025-08762-5","url":null,"abstract":"<p><strong>Background: </strong>Aneurysmal subarachnoid hemorrhage (aSAH) is a dreadful acute neurological condition with an overwhelmingly high rate of associated morbidities and mortality. Despite leaping advancement in neurosurgical techniques and imaging modalities, there is no substantiative improvement in the overall prognosis for aSAH. Cerebral vasospasm remains the predominant cause of associated morbidities. Human albumin has been used in different neurological conditions, including head trauma, intracerebral hemorrhages, and ischemic strokes, with favorable outcomes. However, its beneficial use in aSAH has not been sufficiently explored until recently a published systematic review by our team. In view of the scarcity of published data and lack of robust evidence, our group has designed the first-ever RCT to compare the use of human albumin-enhanced fluid management versus standard fluid therapy with crystalloids in patients with aSAH.</p><p><strong>Methods: </strong>This single-center open-label, prospective, parallel group randomized control trial will be conducted at Hamad General Hospital, Doha, Qatar, from August 2024 to July 2027. A sample size of 84 (42 in each arm) has been calculated to be sufficient to detect a clinically significant difference in the modified Rankin scale good score between two groups (human-albumin induced volume expansion therapy versus crystalloid only) for fluid management in aneurysmal subarachnoid hemorrhage patients. The primary outcome will be based on a dichotomized modified Rankin scale [good grades (0-2) and poor grades (3-6)], while the secondary outcome will include symptomatic vasospasm, transcranial Doppler velocities, and Pulse index Contour Cardiac Output (PiCCO) parameters.</p><p><strong>Discussion: </strong>The trial aims to provide firsthand evidence on the beneficial use of human albumin to achieve an optimal fluid management regime to explore its potential role in improving clinical outcomes in patients with aSAH.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06548477. Registered on August 9, 2024. https://clinicaltrials.gov/search?term=NCT06548477 .</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"53"},"PeriodicalIF":2.0,"publicationDate":"2025-02-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11827198/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143426503","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"TREOCAPA: prophylactic treatment of the ductus arteriosus in preterm infants by acetaminophen-statistical analysis plan for the randomized phase III group sequential trial.","authors":"Moreno Ursino, Corinne Alberti, Gilles Cambonie, Ruth Kemp, Aure Vanhecke, Lea Levoyer, Alpha Diallo, Mikko Hallman, Jean-Christophe Rozé","doi":"10.1186/s13063-025-08751-8","DOIUrl":"10.1186/s13063-025-08751-8","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Persistent patency of the ductus arteriosus (PDA) has challenged neonatologists for more than 40 years. Controversies persist about the management of PDA in extremely preterm infants. PDA is associated with morbidities, but no therapeutic strategy has resulted in an improved neonatal outcome. Acetaminophen appears to be a promising alternative with possibly fewer adverse effects. The primary objective is to determine whether a prophylactic pharmacological intervention with acetaminophen may increase the survival without severe morbidity at postmenstrual age of 36 weeks.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods and analysis: &lt;/strong&gt;TREOCAPA phase III is a randomized, multicenter, double-blind, stratified, placebo-controlled superiority trial, two arms in a 1:1 ratio performed in 43 NICUs of 14 European countries, evaluating whether the intervention increases the survival without severe morbidity by 10%, from 50% in control arm to 60% in treatment arm, until the age of 36 postmenstrual weeks. To detect this difference, 794 patients were required using a group sequential design. Recruitment has been closed, with 803 patients enrolled. Patients eligible for inclusion are preterm infants with a gestational age between 23 and 28 weeks. In the acetaminophen group, 20 mg/kg loading dose within 12 h after birth, followed by 7.5 mg/kg quarter in die (QID) for 5 days, will be administered to the 27-28 weeks gestational age group, and 25 mg/kg loading dose then 10 mg/kg QID will be administered to the 23-26 weeks gestational age group. The severe morbidities include severe bronchopulmonary dysplasia (BPD grade 3) according to NIH consensus, necrotizing enterocolitis (NEC) of Bell's stage II or III, intraventricular hemorrhage (IVH) grade III-IV according to Papile classification, or cystic leukomalacia.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Discussion: &lt;/strong&gt;Whatever the results, the conclusions of this study should be informative for the neonatal scientific community. The results will either confirm the benefit of treatment in increasing survival without severe morbidity, or indicate a worsening of outcomes with prophylactic acetaminophen treatment, or show no difference in the primary outcome. In the latter case, ultrasonographic assessments of ductus arteriosus status on day 7 may help explain the absence of a difference. This could indicate that acetaminophen is ineffective in promoting ductal closure or that early closure of the ductus arteriosus is inconsequential if, despite more frequent closures, there is no associated improvement in outcomes.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Ethics and dissemination: &lt;/strong&gt;Ethical approval of the trial has been performed in each of the 14 countries after approval, at the European level, by the Voluntary Harmonization Procedure committee on 04/07/2020. Results will be disseminated through articles in peer-reviewed journals.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Trial registration: &lt;/strong&gt;European Clinical Trials Database: EudraCT Number: 2019-004297-26.&lt;/p&gt;&lt;p","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"52"},"PeriodicalIF":2.0,"publicationDate":"2025-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11827460/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143415255","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects of lumbar joint mobilization on trunk control, balance, and gait in patients with stroke: study protocol for a randomized controlled trial.","authors":"Can Chen, Bo Yan, Shan He, Ruidi Wu, XiaoHua Han, Yong Chen, Hong Chen, Lingfeng Xie","doi":"10.1186/s13063-025-08767-0","DOIUrl":"10.1186/s13063-025-08767-0","url":null,"abstract":"<p><strong>Background: </strong>After stroke, most patients have impairments in trunk control, balance, and gait. These dysfunctions are closely related to the ability to perform activities of daily living. Therefore, restoring these functions has become the primary rehabilitation goal for stroke patients. Lumbar joint mobilization can activate the spine and surrounding muscles, increase the sensory perception of lumbar joints, restore the stability and symmetry of the trunk. Few studies have focused on the use of lumbar joint mobilization in stroke patients. The purpose of this study was to explore the effects of lumbar joint mobilization on trunk control, balance, and gait in stroke patients.</p><p><strong>Methods: </strong>Sixty stroke patients will be recruited from the Department of Rehabilitation Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology. The participants will be randomly divided into a control group (n = 30) and an intervention group (n = 30). Both groups will receive conventional physical therapy once a day for 4 weeks, 5 days a week. The intervention group will receive an additional 10 min of lumbar joint mobilization at the end of each conventional physical therapy session. The primary outcome measure is the Trunk Impairment Scale (TIS), the secondary outcome measures are Berg Balance Scale (BBS), Time Up & Go test (TUG) and Functional Gait Assessment (FGA). Patients will be assessed for the outcome measures at baseline and at the 4th week at the end of treatment.</p><p><strong>Discussion: </strong>The results of this study will provide preliminary data on the efficacy of lumbar joint mobilization combined with conventional physical therapy on trunk control, balance, and gait in stroke patients.</p><p><strong>Trial registration: </strong>The trial was registered in the Chinese Clinical Trial Registry on September 3, 2023, with the registration number ChiCTR2300075377. The URL of trial registry record: https://www.chictr.org.cn/showproj.html?proj=206313 .</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"50"},"PeriodicalIF":2.0,"publicationDate":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11817543/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143410992","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The effectiveness of vitrectomy co-adjuvant intravitreal dexamethasone implant on visual outcome in patients with proliferative diabetic retinopathy: study protocol for a prospective randomized controlled trial.","authors":"Jipeng Li, Zhaoyang Wang, Aman Chandra, Jun Xu, Lin Liu, Meng Zhao","doi":"10.1186/s13063-025-08758-1","DOIUrl":"10.1186/s13063-025-08758-1","url":null,"abstract":"<p><strong>Background: </strong>Proliferative diabetic retinopathy (PDR) often leads to tractional retinal detachment and vitreous hemorrhage, requiring vitrectomy. Poor visual outcomes are commonly caused by macular edema and proliferative vitreous retinopathy after vitrectomy. Intravitreal dexamethasone implant has shown promise in improving visual function after vitrectomy for diabetic macular edema, but its role in vitrectomy for PDR treatment remains unexplored. This study aims to assess the effectiveness of vitrectomy combined with an intravitreal dexamethasone implant for PDR patients.</p><p><strong>Methods: </strong>We will design a single-mask, randomized controlled trial with 100 participants diagnosed with PDR requiring vitrectomy. Participants will be randomly assigned to either the Ozurdex (0.7 mg dexamethasone intravitreal implant) group or the control group. The dexamethasone implant group will undergo vitrectomy combined with 0.7 mg dexamethasone intravitreal implant, while the control group will undergo vitrectomy alone. A single surgeon will perform all the vitrectomy surgeries, and the choice of intravitreal dexamethasone implant treatment will be disclosed before the closure of scleral wounds. Primary and secondary outcomes will be assessed at baseline and at 4, 8, 12, and 24 weeks post-vitrectomy.</p><p><strong>Statistical analysis: </strong>Statistical analysis will be conducted using R software. A p value 0.05 will be considered statistically significant. The analysis methods will include the following: visual acuity and OCT measurements will be analyzed using repeated measures analysis of variance (ANOVA) with two-tailed tests; rates of visual improvement, visual decline, postoperative vitreous hemorrhage, elevated intraocular pressure, and postoperative retinal detachment will be analyzed using chi-square tests with two-tailed tests. Logistic regression analysis will be used to analyze risk factors for poor visual prognosis, neovascular glaucoma development, and postoperative vitreous hemorrhage occurrence.</p><p><strong>Discussion: </strong>This protocol aims to enhance our understanding of the effects of combining an intravitreal Ozurdex 0.7 mg dexamethasone implant with vitrectomy on visual outcomes and macular morphology changes in treating late complications of PDR.</p><p><strong>Trial registration: </strong>The trial was registered at the Chinese Clinical Trial Registry on May 11, 2022, with registration number ChiCTR2200059760.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"51"},"PeriodicalIF":2.0,"publicationDate":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11823229/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143410995","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Statistical documentation for multi-disease, multi-domain platform trials: our experience with the Staphylococcus aureus Network Adaptive Platform trial.","authors":"Robert K Mahar, Anna McGlothlin, Michael Dymock, Lauren Barina, Marc Bonten, Asha Bowen, Matthew P Cheng, Nick Daneman, Anna L Goodman, Todd C Lee, Roger J Lewis, Thomas Lumley, Alistair R D McLean, Zoe McQuilten, Jocelyn Mora, David L Paterson, David J Price, Jason Roberts, Tom Snelling, Jonas Tverring, Steve A Webb, Dafna Yahav, Joshua S Davis, Steven Y C Tong, Julie A Marsh","doi":"10.1186/s13063-024-08684-8","DOIUrl":"10.1186/s13063-024-08684-8","url":null,"abstract":"<p><p>Platform trials have become widely adopted across multiple disease areas over recent years, however, guidelines for operationalising these trials have not kept pace. We outline a series of documents that summarise the statistical components, and implicit processes, of the Staphylococcus aureus Network Adaptive Platform (SNAP) trial to provide an informal template for other researchers and reviewers of platform trials. We briefly summarise the content and role of the core protocol, statistical appendix, domain-specific appendices, simulation report, statistical implementation guides, data safety and monitoring committee (DSMC) reports, and domain-specific statistical analysis plans and final reports, and a transparent governance structure that ensures separate blinded and unblinded statistical teams. In the absence of guidelines or checklists for platform trial statistical documents, we hope to provide useful guidance to others in terms of what has worked so far for the SNAP trial, stimulate discussion, and inform a future consensus.Trial registration NCT05137119 . Registered on 30 November 2021.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"49"},"PeriodicalIF":2.0,"publicationDate":"2025-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11817021/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143400303","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparison of the effects of transcranial direct current stimulation and transcutaneous tibial nerve stimulation on the urgency and frequency of women with overactive bladder syndrome: study protocol of a randomized clinical trial.","authors":"Zahra Gorji, MohammadReza Hadian Rasanani, Michael Nitsche, Tannaz Ahadi, Roya Khanmohammadi, Mona Gorji, Roxana Bazaz Behbahani, Vahid Rafiei Manesh","doi":"10.1186/s13063-025-08738-5","DOIUrl":"10.1186/s13063-025-08738-5","url":null,"abstract":"<p><strong>Background: </strong>Overactive bladder syndrome is common, with a prevalence of 12-17% among adults. Posterior tibial nerve stimulation is the primary nonpharmacological and conservative treatment for overactive bladder syndrome. While several human brain imaging studies have shown the involvement of supraspinal centers in bladder control, a literature review has found that no research has specifically investigated cortical stimulation through transcranial direct current stimulation as a treatment for overactive bladder syndrome in women. Therefore, this study aims to assess the potential benefits of transcranial direct current stimulation (tDCS) and compare them with the effects of posterior tibial nerve stimulation on overactive bladder syndrome.</p><p><strong>Methods/design: </strong>The random allocation method will be used to divide the participants into two groups. Group 1 (n = 19) will undergo pelvic floor muscle training and transcutaneous tibial nerve stimulation. Group 2 (n = 19) will undergo pelvic floor muscle training and transcranial direct current stimulation. The transcranial direct current stimulation for group 2 will consist of 12 sessions occurring thrice a week, each lasting for 20 min. Anodal tDCS will be administered to FPz targeting the medial prefrontal cortex (mPFC) for 12 sessions, with the cathode electrode positioned between Oz and inion at an intensity of 2 mA for 20 min.</p><p><strong>Discussion: </strong>It is believed that utilizing an approach involving non-invasive electrical stimulation of the cortex could lead to a more efficient treatment for individuals with overactive bladder. Additionally, it is theorized that combining the effects of tDCS and pelvic floor muscle training could present an innovative technique for alleviating the negative impacts of overactive bladder syndrome. Ultimately, this new method could provide help for patients who have not responded to conventional therapy.</p><p><strong>Trial registration: </strong>Iranian Registry of Clinical Trials (IRCT) ID: IRCT20090301001722N26, registration date: May 17, 2023. https://en.irct.ir/ .</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"48"},"PeriodicalIF":2.0,"publicationDate":"2025-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11809105/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143383074","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects of monitoring dietary biomarkers and providing vegetable juice on metabolic syndrome components in adults with an overweight or obese body mass index in Ulaanbaatar: a randomized controlled trial.","authors":"Erina Tamaru, Yusuke Ushida, Hiroyuki Suganuma, Bayasgalan Jambaldorj, Oyundelger Dechinjamts, Tuvshinbayar Bayaraa, Tuul Bayarmagnai, Batjargal Jamiyan, Narantuya Davaakhuu, Suvd Batbaatar, Unursaikhan Surenjav, Narmisheekh Khasag","doi":"10.1186/s13063-024-08712-7","DOIUrl":"10.1186/s13063-024-08712-7","url":null,"abstract":"<p><strong>Background: </strong>Mongolian people have traditionally had poor vegetable intake habits, which is a cause of increasing prevalence of metabolic syndrome. Monitoring vegetable intake through the dietary biomarkers such as skin carotenoid level, and urinary sodium-to-potassium (Na/K) ratio (represents intake status of salt and vegetable), has been recently suggested to be useful to improve dietary habits. Vegetable juices are an easy way to consume vegetable-derived ingredients. This study aimed to examine the following two points in adults with an overweight or obese body mass index (BMI) in Ulaanbaatar; (1) relationships between these dietary biomarkers and metabolic syndrome components, and (2) effects of an intervention combining regular monitoring of these dietary biomarkers and provision of vegetable juices on values of the dietary biomarkers and metabolic syndrome components.</p><p><strong>Methods: </strong>Ninety-four Mongolian adults with BMI ≥ 25 living in Ulaanbaatar were analyzed. (1) Relationships between baseline values of dietary biomarkers and metabolic syndrome components were analyzed by simple correlation and multiple regression analyses. (2) Participants were randomly allocated to control, monitoring, and monitoring + vegetable juice groups. During the 8-week intervention, the monitoring and monitoring + vegetable juice groups were monitored their dietary biomarkers and blood pressure every two weeks, and the monitoring + vegetable juice group was additionally provided with vegetable juice every day. Changes in dietary biomarkers and metabolic syndrome components before and after intervention were compared among the three groups.</p><p><strong>Results: </strong>(1) The skin carotenoid levels were negatively correlated with blood triglyceride levels, whereas the urinary Na/K ratio was positively associated with systolic and diastolic blood pressure. (2) Through the intervention, the monitoring + vegetable juice group showed significant increase in skin carotenoid level (+ 1.72), decrease in urinary Na/K ratio (- 0.80 mol/mol), and decrease in waist circumference (- 2.63 cm) compared to the control group (+ 0.28, + 0.45, and + 0.22, respectively).</p><p><strong>Conclusions: </strong>The combination of the monitoring dietary biomarkers and providing vegetable juice was suggested to be effective in improving dietary habits and metabolic syndrome components including waist circumference in Mongolian adults with an overweight or obese BMI.</p><p><strong>Trial registration: </strong>UMIN-CTR Clinical Trial UMIN000051715 on July 26, 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"47"},"PeriodicalIF":2.0,"publicationDate":"2025-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11808956/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143383099","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety reporting in neonatal clinical trials: reflections towards optimal, globally relevant approaches.","authors":"Louise F Hill, Christina W Obiero, Adrie Bekker, Ann Sarah Walker, Julia A Bielicki, Mike Sharland, Francesca Schiavone","doi":"10.1186/s13063-025-08723-y","DOIUrl":"10.1186/s13063-025-08723-y","url":null,"abstract":"<p><p>Adverse event (AE) collection is a key part of evidence generation in clinical trials and an integral element of safety reporting. AE assessment and documentation is particularly challenging in neonates who are a heterogeneous population with high rates of co-morbidities. Neonatal research is finally gaining the attention of regulators regarding drug development and the need for optimal dosing specific to this population. However, further efforts are necessary to ensure that adverse events (AEs) are adequately collected, allowing for the generation of essential safety data. It is also crucial that the methodology used aligns with the intended trial outcomes to minimise the burden on trial sites. In resource-constrained settings, where pharmacovigilance implementation can be particularly challenging, a pragmatic approach to safety reporting is even more important given the significant public health need for effective drugs. This commentary reflects on some of the challenges and potential areas of improvement in safety reporting that could be addressed in future neonatal-focused trials.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"46"},"PeriodicalIF":2.0,"publicationDate":"2025-02-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11808976/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143383107","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}